51ÁÔÆæ

Extractables and leachables (E&L) assessments play an important role in demonstrating that pharmaceutical products, packaging components, and manufacturing materials are suitable for their intended use. In this Ask the Expert article, Susan J. Schniepp of 51ÁÔÆæ explains when companies should evaluate and submit E&L data to regulatory authorities. Although regulatory requirements establish the need to ensure that containers, closures, and manufacturing equipment do not adversely affect product quality or safety, there is no single rule defining when E&L information must be submitted.

The timing depends on several factors, including the type of product, its formulation, packaging materials, and manufacturing processes. For example, generic products using the same active ingredients and packaging components as an approved reference product may be able to provide E&L information later in development. In contrast, novel products, reformulated products, biologics, combination products, and products using unique packaging or single-use manufacturing systems may require earlier evaluation. Manufacturing equipment such as filters and tubing should also be considered as potential sources of extractables and leachables.

Schniepp emphasizes the value of conducting a risk evaluation early in development to determine when E&L data should be generated and made available to regulators. By identifying potential sources of leachables and assessing their impact on product quality and patient safety, companies can better plan their testing and regulatory submissions. A proactive approach helps reduce the risk of regulatory delays and supports a smoother product approval process.

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